市场监管总局（标准委）推动33项疫情防控国际标

作者：张馨予

为充分发挥标准技术优势，助力应对全球新冠肺炎疫情，有力支持企业复工复产达产，市场监管总局（标准委）积极与国际标准化组织（ISO）、国际电工委员会（IEC）沟通联系，推动疫情防控相关国际标准免费向社会公开。在获得ISO、IEC授权同意后，市场监管总局（标准委）迅速组织在中国标准信息服务网上，免费公开了医用肺呼吸机、防护服、医疗器械生物学评价等33项疫情防控相关国际标准，为战胜疫情贡献标准力量。
中国是ISO、IEC的常任理事国，保护国际标准版权是我们应尽的责任和义务。为此，在公开标准的同时，我们严格遵守ISO、IEC国际标准版权政策要求，切实履行国际标准版权保护的责任和义务。
附：33项疫情防控国际标准清单
1
ISO 374-5:2016
Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
危险化学品和微生物防护手套——第5部分:微生物风险的术语和性能要求
2
ISO 10993-1:2018
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
医疗器械生物学评价——第1部分：风险管理过程中的评价与试验
3
ISO 13688:2013
Protective clothing – General requirements
防护服——一般要求
4
ISO 22301:2019
Security and resilience – Business continuity management systems –Requirements
安全性及恢复能力——商业连续性管理系统——要求
5
ISO 22395:2018
Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
安全性及恢复能力——社区恢复能力——紧急情况下支持弱势人群的准则
6
ISO 22320:2018
Security and resilience – Emergency management – Guidelines for incident management
安全性及恢复能力——应急管理——事故管理指南
7
ISO 22316:2017
Security and resilience – Organizational resilience – Principles and attributes
安全性及恢复能力——组织机构恢复能力——原则和属性
8
ISO 31000:2018
Risk management – Guidelines
风险管理——指南
9
ISO 10651-3:1997
Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators
医用肺呼吸机——第3部分：急救和运送用呼吸机的特殊要求
10
ISO 10651-4:2002
Lung ventilators — Part 4: Particular requirements for operatorpowered resuscitators
肺呼吸机——第4部分：操作员控制用人工呼吸机的特殊要求
11
ISO 10651-5:2006
Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators
医用肺呼吸机——基本安全和基本性能的特殊要求——第5部分:气动急救人工呼吸器
12
ISO 13485:2016
Medical devices — Quality management systems - Requirements for regulatory purposes
医疗器械——质量管理体系——监管要求
13
ISO 17510:2015
Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
医疗器械——睡眠窒息呼吸治疗——面罩和应用附件
14
ISO 18082:2014
Anaesthetic and respiratory equipment — Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1]
麻醉剂和呼吸设备——医疗气体用非交替式螺栓.螺纹(NIST)低压力连接器尺寸 [包括ISO 18082:2014/Amd.1:2017, 修订 1]
15
ISO 18562-1:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
医疗保健应用中呼吸气体通道的生物相容性评估——第1部分: 风险管理过程中的评估和试验
16
ISO 18562-2:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
医疗保健应用中呼吸气体通道的生物相容性评估——第2部分: 颗粒物排放试验
17
ISO 18562-3:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)
医疗保健应用中呼吸气体通道的生物相容性评估——第3部分: 挥发性有机化合物(VOC)排放试验
18
ISO 18562-4:2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
医疗保健应用中呼吸气体通道的生物相容性评估——第4部分: 冷凝物中的析出物试验
19
ISO 19223:2019
Lung ventilators and related equipment — Vocabulary and semantics
呼吸机及相关设备——词汇和语义
20
ISO 20395:2019
Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
生物技术——核酸目标序列量化方法性能评估要求——qPCR和dPCR（实时荧光定量聚合酶链式反应和数字聚合酶链式反应）
21
ISO 5356-1:2015
Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
麻醉剂和呼吸设备——锥形连接器——第1部分:锥体和插孔
22
ISO 80601-2-12:2020
Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
医用电气设备——第2-12部分：重症监护呼吸机基本安全和基本性能的特殊要求
23
ISO 80601-2-13:2011
Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]
医疗电气设备——第2-13部分: 麻醉工作站的基本安全和基本性能的特殊要求[包括 ISO 80601-2-13:2011/Amd.1:2015, 修订 1 和 ISO 80601-2-13:2011/Amd.2:2018, 修订 2]
24
ISO 80601-2-70:2015
Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
医疗电气设备——第2-70部分：睡眠窒息呼吸治疗设备的基本安全和基本性能的特殊要求
25
ISO 80601-2-74:2017
Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
医疗电气设备——第2-74部分: 呼吸加湿器基本安全和基本性能的特殊要求
26
ISO 80601-2-79:2018
Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
医疗电气设备——第2-79部分：呼吸受损的呼吸支持设备基本安全和基本性能的特殊要求
27
ISO 80601-2-80:2018
Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
医疗电气设备——第2-80部分：呼吸功能不全的呼吸支持设备基本安全和基本性能的特殊要求
28
ISO/TS 16976-8:2013
Respiratory protective devices — Human factors — Part 8: Ergonomic factors
呼吸保护装置——人为因素——第8部分:人体工学因素
29
IEC 60601-1:2005+AMD1:2012 CSV
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
医用电气设备——第1部分：基本安全和基本性能
30
IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
医用电气设备——第1-2部分：基本安全和基本性能的通用要求——汇编标准：电磁干扰-要求和测试
31
IEC 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
医用电气设备——第1-6部分：基本安全性和必要性能的通用要求——汇编标准：可用性
32
IEC 60601-1-8:2006
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
医用电气设备——第1-8部分：基本安全和基本性能的通用要求——汇编标准：医疗电气设备和医疗电气系统报警系统的通用要求、试验和指南
33
IEC 60601-1-11:2015
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
医疗电气设备——第1-11部分：基本安全和基本性能的通用要求——汇编标准：家庭保健用医疗电气设备和医疗电气系统的要求